Objective: To evaluate the long-term safety and efficacy of lurasidone.
Methods: Clinically stable outpatients with schizophrenia who completed 12 months of flexibly dosed lurasidone (40-120 mg/d) or risperidone (2-6 mg/d) in a randomized, double-blind, active-controlled safety study were eligible for a 6-month open-label extension (OLE) study with flexibly dosed lurasidone (40-120 mg/d).
Results: The OLE study enrolled 136 patients continued on lurasidone (LUR-LUR) and 87 patients switched from risperidone (RIS-LUR). During the double-blind study, mean weight increased (2.3 kg) in RIS-LUR patients but decreased in LUR-LUR patients (-1.0 kg). During the OLE, mean change in weight was -0.6 kg for LUR-LUR and -2.9 kg for RIS-LUR patients (observed cases [OC]). During the double-blind study, median prolactin level increased in RIS-LUR patients (men, 12.8 ng/mL; women, 35.2 ng/mL) but decreased in LUR-LUR patients (men, -0.6 ng/mL; women, -0.8 ng/mL). During the OLE, median prolactin levels showed little change in LUR-LUR patients and decreased in RIS-LUR patients (median change from OLE baseline to endpoint [OC]: men, -11.2 ng/mL; women, -30.8 ng/mL). Mean Positive and Negative Syndrome Scale total score was 55.5 at OLE baseline, and mean change at month 6 of the OLE was 0.6 in both the LUR-LUR and RIS-LUR groups (OC).
Conclusions: In this 6-month OLE study, switching to lurasidone after 12 months of double-blind treatment with risperidone was associated with decreased weight and prolactin levels. Lurasidone effectively maintained clinical stability, both in patients who transitioned from risperidone and those who continued on lurasidone. ClinicalTrials.gov identifier: NCT00641745